Patient and clinician collaboration in the design of a national randomized breast cancer trial.

Marsden, J., Bradburn, J. on behalf of the Consumers' Advisory Group for Clinical Trials* (CAG-CT) and the Lynda Jackson Macmillan Centre
(2004)
Patient and clinician collaboration in the design of a national randomized breast cancer trial.
HEALTH EXPECTATIONS: AN INTERNATIONAL JOURNAL OF PUBLIC PARTICIPATION IN HEALTH CARE AND HEALTH POLICY., 7 (1).
pp. 6-17.
ISSN 1369-6513

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Abstract

Patient and clinician collaboration in the design of a national randomized breast cancer trial Objective To show breast cancer patient involvement in the design of a national randomized trial of hormone replacement therapy (HRT) in symptomatic patients will increase accrual. Setting and participants Three stakeholder groups [(1) researchers from the Lynda Jackson Macmillan Centre, (2) the Consumers' Advisory Group for Clinical Trials (CAG-CT), (3) clinicians responsible for a pilot randomized HRT study in breast cancer patients] developed this collaborative study. Methods (1) Nine focus group discussions were conducted to identify issues relevant to breast cancer patients about HRT and a national trial: six involved women from breast cancer support groups nationwide and three patients who had previously participated in the pilot randomized HRT study. (2) Recommendations from the focus groups (analysed by Grounded Theory) were debated by the research stakeholders and focus group representatives at a 1-day meeting and consensus reached (using a voting system) on mutual priorities for incorporation into the design of a national HRT trial. (3) Representatives from the CAG-CT and focus groups participated in subsequent national HRT steering committee meetings to ensure that these priorities were accounted for and the resulting trial design summary was circulated to the CAG-CT and all focus group representatives for comment. Results Focus groups demonstrated that the complexity of factors relating to trial participation was not just restricted to the research topic in question. Patient-clinician interaction provided a platform for negotiating potential conflicts over trial design and outcomes. Patient feedback suggested that mutually agreed priorities were accounted for in the trial design. Interpretation Clinical research planning should involve all research stakeholders at the outset. Quantifying the impact of patient involvement in terms of trial accrual may be too simple given the complexity of their motivations for participating in trials.(C) Blackwell Publishing Ltd 2004 Health Expectations, 7, pp.6-17.

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Marsden, J., Bradburn, J. on behalf of the Consumers' Advisory Group for Clinical Trials* (CAG-CT) and the Lynda Jackson Macmillan Centre